Keros Therapeutics to Participate in Two Upcoming Healthcare Conferences

LEXINGTON, Mass., Sept. 02, 2021 (GLOBE NEWSWIRE) — Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need, today announced that Keros’ President and Chief Executive Officer Jasbir S. Seehra, Ph.D., will participate in two upcoming healthcare conferences.

Presentation Details:

Event: Morgan Stanley 19th Annual Global Healthcare Conference
Date/Time: Friday, September 10 at 11:00 AM ET
Format: Fireside Chat

Event: H.C. Wainwright 23rd Annual Global Investment Conference
Date/Time: Available on Monday, September 13 starting at 7:00 AM ET
Format: Corporate Presentation

The Morgan Stanley fireside chat presentation will be webcast live at https://morganstanley.webcasts.com/starthere.jsp?ei=1488923&tp_key=f6a26a9322 and the H.C. Wainwright presentation will be available at https://journey.ct.events/view/2af63db8-a98e-40f7-bb4e-4fc6d4b18ba0. Both will be archived in the Investors section of the Keros website at https://ir.kerostx.com/. A replay will be available for 90 days following the conclusion of the event.

About Keros Therapeutics, Inc.

Keros is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel treatments for patients suffering from hematologic and musculoskeletal disorders with high unmet medical need. Keros is a leader in understanding the role of the transforming growth factor-Beta, or TGF-ß, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. Keros’ lead protein therapeutic product candidate, KER-050, is being developed for the treatment of low blood cell counts, or cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndromes and in patients with myelofibrosis. Keros’ lead small molecule product candidate, KER-047, is being developed for the treatment of anemia resulting from iron imbalance, as well as for the treatment of fibrodysplasia ossificans progressiva. Keros’ third product candidate, KER-012, is being developed for the treatment of disorders associated with bone loss, such as osteoporosis and osteogenesis imperfecta, and for the treatment of pulmonary arterial hypertension.

Investor Contact:

Mike Biega
[email protected] 
(617) 221-9660



Kaleyra to Present at the 10th Annual Gateway Conference on September 9, 2021

Kaleyra to Present at the 10th Annual Gateway Conference on September 9, 2021

NEW YORK & VIENNA, Va.–(BUSINESS WIRE)–Kaleyra, Inc. (NYSE:KLR) (NYSE American:KLR WS) (“Kaleyra” or the “Company”), a rapidly growing cloud communications software provider delivering a secure system of application programming interfaces (APIs) and connectivity solutions in the API/Communications Platform as a Service (CPaaS) market, has been invited to present at the 10th Annual Gateway Conference, which is being held virtually on September 8-9, 2021.

Kaleyra management is scheduled to present on Thursday, September 9th at 7:30 a.m. Pacific time, with one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay here.

To receive additional information, request an invitation or to schedule a one-on-one meeting, please email [email protected].

About the Gateway Conference

For the past nine years, the Gateway Conference has engaged the management teams of nearly 800 public and private growth companies and thousands of institutional investors, sell-side analysts and sponsoring investment bankers. Past attendees have valued the event for its direct access to high-quality companies and investors. Follow the Gateway Conference on Twitter and join the conversation using the #GatewayIRConference hashtag. For more information, visit gateway-grp.com/conference/.

About Kaleyra

Kaleyra, Inc. (NYSE:KLR) (NYSE American:KLR WS) is a global group providing mobile communication services to financial institutions, e-commerce players, OTTs, software companies, logistic enablers, healthcare providers, retailers, and other large organizations worldwide.

Kaleyra today has a customer base of 3800+ companies spread around the world. Through its proprietary platform and robust APIs, Kaleyra manages multi-channel integrated communication services, consisting of messaging, rich messaging and instant messaging, video, push notifications, e-mail, voice services, and chatbots.

Kaleyra’s technology makes it possible to safely and securely manage billions of messages monthly with over 1600 operator connections in 190+ countries, including all tier-1 US carriers.

Investors:

Tom Colton or Matt Glover

Gateway Investor Relations

949-574-3860

[email protected]

KEYWORDS: United States North America New York Virginia

INDUSTRY KEYWORDS: Technology VoIP Audio/Video Telecommunications Mobile/Wireless Software Internet

MEDIA:

Logo
Logo

Ayala Pharmaceuticals to Participate in Upcoming Virtual Investor Conferences

REHOVOT, Israel and WILMINGTON, Del., Sept. 02, 2021 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced that Ayala management will participate in two upcoming virtual investor conferences in September:

  • H.C. Wainwright 23rd Annual Global Investor Conference: Corporate Presentation available on-demand starting Monday, September 13, 2021 at 7:00 am ET.
  • Citi’s 16th Annual Biopharma Virtual Conference: Management will participate in investor meetings on Thursday, September 9, 2021.

A webcast of the H.C. Wainwright 23rd Annual Global Investor Conference presentation may be accessed by visiting the Events & Presentations section of Ayala’s website at ir.ayalapharma.com. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

About Ayala Pharmaceuticals

Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including Adenoid Cystic Carcinoma, Triple Negative Breast Cancer (TNBC), T-cell Acute Lymphoblastic Leukemia (T-ALL), Desmoid Tumors and Multiple Myeloma (MM) (in collaboration with Novartis). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations and in a Phase 2 clinical trial for patients with TNBC (TENACITY) bearing Notch activating mutations and other gene rearrangements. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE) and is being evaluated in a Phase 1 clinical trial in combination with Novartis’ BMCA targeting agent, WVT078, in Patients with relapsed/refractory Multiple Myeloma. For more information, visit www.ayalapharma.com.

Investors:

Julie Seidel
Stern Investor Relations, Inc.
+1-212-362-1200
[email protected]

Ayala Pharmaceuticals:

+1-857-444-0553
[email protected]



American Eagle Outfitters Reports All-time High Second Quarter Revenue and Operating Income Reflecting Strength Across Brands and Great Progress on our “Real Power. Real Growth.” Value Creation Plan

American Eagle Outfitters Reports All-time High Second Quarter Revenue and Operating Income Reflecting Strength Across Brands and Great Progress on our “Real Power. Real Growth.” Value Creation Plan

Second Quarter 2021 Highlights Compared to Second Quarter 2020

  • Record revenue of $1.19 billion increased 35%
  • Operating income reached an all-time second quarter high of $168 million
  • Higher full-priced sales, reduced promotions and controlled costs fueled gross margin expansion to 42.1%
  • Aerie net revenue increased 34%, operating income rose 132%, reflecting a 21.0% operating margin
  • American Eagle net revenue rose 35%, operating income was up 234%, reflecting a 23.5% operating margin

PITTSBURGH–(BUSINESS WIRE)–
American Eagle Outfitters, Inc. (NYSE: AEO) today announced financial results for the second quarter ended July 31, 2021.

“It’s extremely gratifying to see significant growth across our business, as we delivered another quarter of record revenue and profitability. Results underscore the strength of our brands, outstanding product and a leading customer experience across selling channels. We are running our business with a laser focus on profitability through inventory and real-estate optimization initiatives and investments to enhance our supply chain. Led by an expanding customer file, Aerie is achieving consistent, robust multi-year growth and very strong profit flow through. American Eagle posted meaningful top-and bottom-line increases with significant unlock still ahead. Our Real Power. Real Growth. plan has been a guiding light for all facets of the business, positioning us to successfully navigate a dynamic macro environment. Despite external challenges, I believe we are on path to achieve $600 million in operating income this year, well ahead of our previous target,” said Jay Schottenstein, AEO’s Executive Chairman of the Board and Chief Executive Officer.”

Second Quarter 2021 Results

  • Total net revenue increased $311 million, or 35% to $1.19 billion, compared to $0.88 billion in the second quarter of 2020.
  • Aerie revenue of $336 million rose 34% from second quarter 2020 on top of 32% growth last year. American Eagle revenue of $846 million rose 35% versus second quarter 2020 following a 26% decline last year.
  • Consolidated store revenue increased 73% from second quarter 2020 due to an improvement in store traffic. Total online demand this quarter was up 9%. Digital revenue decreased 5% from second quarter 2020 reflecting the natural channel shift associated with improved store traffic across the US. Last year, the abrupt acceleration in digital also created a significant fulfillment backlog that shifted sales from the first quarter into the second quarter in 2020. Compared to the pre-pandemic second quarter 2019 base, store revenue increased 4% and digital revenue increased 66%.
  • Gross profit of $502 million rose 89% from $265 million in the second quarter of 2020.
  • Gross margin of 42.1% expanded 1210 basis points from 30% in the second quarter of 2020. The increase from 2020 reflected significant revenue and merchandise margin expansion across brands, primarily driven by strong demand, higher full-priced sales, lower promotions and inventory optimization initiatives. Rent, digital delivery expenses and compensation also leveraged.
  • Selling, general and administrative expense leveraged 70 basis points as a rate to sales versus second quarter 2020 due to strong revenue growth. On a dollar basis, SG&A increased due largely to the re-opening of our stores. We also saw increased advertising as well as incentive costs.
  • Depreciation and amortization expense of $40 million compared to $39 million in the second quarter of 2020 and leveraged 100 basis points as a rate to sales due to strong revenue growth, asset impairments, as well as lower capital spending in 2020.
  • Operating income of $168 million compared to an operating loss of $12 million in second quarter 2020, or operating income of $2 million on an adjusted basis. Aerie’s operating income of $71 million increased 132% from $30 million in the second quarter of 2020 and American Eagle’s operating income of $199 million increased 234% from $60 million in the second quarter of 2020.
  • Operating margin of 14.1% reflected the highest rate since 2008. Aerie operating margin of 21.0% expanded 890 bps from 2020 and American Eagle’s operating margin of 23.5% expanded 1400 bps from 2020.
  • Average diluted shares outstanding were 209 million compared to 166 million in the second quarter of 2020. The increase primarily reflected 36 million shares of unrealized dilution associated with the company’s convertible notes.
  • EPS of $0.58 this quarter. Adjusted EPS of $0.60 this quarter excludes $0.02 of non-cash interest expense on the company’s convertible notes.

Inventory

Total consolidated ending inventory at cost increased $82 million or 20% to $504 million compared to a 21% decline last year. Inventory was up across both brands, positioned in key Fall categories, yet remained below revenue growth, which is consistent with our focus on inventory optimization.

Capital Expenditures

In the second quarter of 2021, capital expenditures totaled $49 million, and year to date totaled $86 million. For fiscal 2021, the company now expects capital expenditures to be at the lower end of our prior guidance range of $250 to $275 million.

Cash Flow and Balance Sheet

The company ended the period with total cash and short-term investments of $824 million. This compares to $899 million in second quarter 2020 which included $200 million from AEO’s revolving credit facility, repaid in third quarter 2020.

Shareholder Returns

As previously announced, the Board of Directors of AEO approved a 31% increase in the quarterly dividend in June 2021 from $0.1375 to $0.18 per share. The company’s second quarter cash dividend of $30 million was paid during the quarter.

Conference Call and Supplemental Financial Information

Today, management will host a conference call and real time webcast at 9:00 a.m. Eastern Time. To listen to the call, dial 1-877-407-0789 or internationally dial 1-201-689-8562 or go to www.aeo-inc.com to access the webcast and audio replay. Additionally, a financial results presentation is posted on the company’s website.

Non-GAAP Measures

This press release includes information on non-GAAP financial measures (“non-GAAP” or “adjusted”), including consolidated adjusted operating income and earnings per share, excluding non-GAAP items. These financial measures are not based on any standardized methodology prescribed by U.S. generally accepted accounting principles (“GAAP”) and are not necessarily comparable to similar measures presented by other companies. Non-GAAP information is provided as a supplement to, not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Management believes that this non-GAAP information is useful for an alternate presentation of the company’s performance, when reviewed in conjunction with the company’s GAAP consolidated financial statements, as it helps identify underlying trends in our business that could otherwise be masked by the effect of the items that we exclude in such non-GAAP measures. Accordingly, we believe that adjusted operating income provides useful information to investors and others in understanding and evaluating our operating results, enhancing the overall understanding of our past performance and future prospects, and allowing for greater transparency with respect to the key financial metrics used by our management in our financial and operational decision-making.

These amounts are not determined in accordance with GAAP and therefore, should not be used exclusively in evaluating the company’s business and operations. We encourage investors and others to review our financial information in its entirety, not to rely on any single financial measure and to view these non-GAAP financial measures in conjunction with the related GAAP financial measures.

About American Eagle Outfitters, Inc.

American Eagle Outfitters, Inc. (NYSE: AEO) is a leading global specialty retailer offering high-quality, on-trend clothing, accessories and personal care products at affordable prices under its American Eagle® and Aerie® brands. Our purpose is to show the world that there’s REAL power in the optimism of youth. The company operates stores in the United States, Canada, Mexico, and Hong Kong, and ships to 81 countries worldwide through its websites. American Eagle and Aerie merchandise also is available at more than 200 international locations operated by licensees in 33 countries. For more information, please visit www.aeo-inc.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This release and related statements by management contain forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995), which represent our expectations or beliefs concerning future events, including third quarter and annual fiscal 2021 results. All forward-looking statements made by the company involve material risks and uncertainties and are subject to change based on many important factors, some of which may be beyond the company’s control. Words such as “estimate,” “project,” “plan,” “believe,” “expect,” “anticipate,” “intend,” “potential,” and similar expressions may identify forward-looking statements. Except as may be required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events or otherwise and even if experience or future changes make it clear that any projected results expressed or implied therein will not be realized. The following factors, in addition to the risks disclosed in Item 1A., Risk Factors, of our Annual Report on Form 10-K for the fiscal year ended January 30, 2021 and in any other filings that we may make with the Securities and Exchange Commission in some cases have affected, and in the future could affect, the company’s financial performance and could cause actual results for fiscal 2021 and beyond to differ materially from those expressed or implied in any of the forward-looking statements included in this release or otherwise made by management: the negative impacts of the COVID-19 pandemic and related operational disruptions; the risk that the company’s operating, financial and capital plans may not be achieved; our inability to anticipate customer demand and changing fashion trends and to manage our inventory commensurately; seasonality of our business; our inability to achieve planned store financial performance; our inability to react to raw material cost, labor and energy cost increases; our inability to gain market share in the face of declining shopping center traffic; our inability to respond to changes in e-commerce and leverage omni-channel demands; our inability to expand internationally; difficulty with our international merchandise sourcing strategies; challenges with information technology systems, including safeguarding against security breaches; and global economic, public health, social, political and financial conditions, and the resulting impact on consumer confidence and consumer spending, as well as other changes in consumer discretionary spending habits, which could have a material adverse effect on our business, results of operations and liquidity.

 
AMERICAN EAGLE OUTFITTERS, INC.
CONSOLIDATED BALANCE SHEETS
(Dollars in thousands)
(unaudited)
 

July 31,

 

January 30,

 

August 1,

2021

 

2021

 

2020

ASSETS
Cash and cash equivalents

$

773,994

 

$

850,477

 

$

898,787

 

Short-term investments

 

50,000

 

 

 

 

 

Merchandise inventory

 

503,507

 

 

405,445

 

 

421,196

 

Accounts receivable

 

155,361

 

 

146,102

 

 

107,243

 

Prepaid expenses and other

 

118,721

 

 

120,619

 

 

155,141

 

Total current assets

 

1,601,583

 

 

1,522,643

 

 

1,582,367

 

Property and equipment, net

 

641,396

 

 

623,808

 

 

659,351

 

Operating lease right-of-use assets

 

1,103,247

 

 

1,155,965

 

 

1,271,491

 

Intangible assets, including goodwill

 

70,620

 

 

70,332

 

 

51,432

 

Non-current deferred income taxes

 

46,600

 

 

33,045

 

 

30,224

 

Other assets

 

31,576

 

 

29,013

 

 

33,111

 

Total Assets

$

3,495,022

 

$

3,434,806

 

$

3,627,976

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts payable

$

221,471

 

$

255,912

 

$

295,296

 

Current portion of operating lease liabilities

 

288,534

 

 

328,624

 

 

348,921

 

Accrued compensation and payroll taxes

 

133,185

 

 

142,272

 

 

66,131

 

Other current liabilities and accrued expenses

 

56,568

 

 

55,343

 

 

51,281

 

Unredeemed gift cards and gift certificates

 

44,095

 

 

62,181

 

 

43,165

 

Accrued income taxes and other

 

25,365

 

 

14,150

 

 

12,783

 

Dividends payable

 

 

 

 

 

22,837

 

Total current liabilities

 

769,218

 

 

858,482

 

 

840,414

 

Non-current operating lease liabilities

 

1,094,386

 

 

1,148,742

 

 

1,253,105

 

Long-term debt, net

 

331,680

 

 

325,290

 

 

516,953

 

Other non-current liabilities

 

24,207

 

 

15,627

 

 

19,604

 

Total non-current liabilities

 

1,450,273

 

 

1,489,659

 

 

1,789,662

 

Commitments and contingencies

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

2,496

 

 

2,496

 

 

2,496

 

Contributed capital

 

630,506

 

 

663,718

 

 

647,284

 

Accumulated other comprehensive loss

 

(36,894

)

 

(40,748

)

 

(47,991

)

Retained earnings

 

2,058,448

 

 

1,868,613

 

 

1,807,687

 

Treasury stock

 

(1,379,025

)

 

(1,407,414

)

 

(1,411,576

)

Total stockholders’ equity

 

1,275,531

 

 

1,086,665

 

 

997,900

 

Total Liabilities and Stockholders’ Equity

$

3,495,022

 

$

3,434,806

 

$

3,627,976

 

Current Ratio

 

2.08

 

 

1.77

 

 

1.88

 

 
AMERICAN EAGLE OUTFITTERS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars and shares in thousands, except per share amounts)
(unaudited)
 
GAAP Basis
13 Weeks Ended
July 31, % of August 1, % of

2021

Revenue

2020

Revenue

Total net revenue

$

1,194,156

 

100.0

%

$

883,510

 

100.0

%

Cost of sales, including certain buying, occupancy and warehousing expenses

 

691,765

 

57.9

%

 

618,311

 

70.0

%

Gross profit

 

502,391

 

42.1

%

 

265,199

 

30.0

%

Selling, general and administrative expenses

 

293,939

 

24.6

%

 

223,711

 

25.3

%

Impairment, restructuring and COVID-19 related charges

 

 

0.0

%

 

14,611

 

1.7

%

Depreciation and amortization expense

 

40,456

 

3.4

%

 

39,114

 

4.4

%

Operating income (loss)

 

167,996

 

14.1

%

 

(12,237

)

-1.4

%

Interest expense (income), net

 

8,921

 

0.8

%

 

8,547

 

1.0

%

Other (income) expense, net

 

(1,363

)

-0.1

%

 

(1,554

)

-0.2

%

Income (loss) before income taxes

 

160,438

 

13.4

%

 

(19,230

)

-2.2

%

Provision (benefit) from income taxes

 

38,927

 

3.2

%

 

(5,478

)

-0.6

%

Net income (loss)

$

121,511

 

10.2

%

$

(13,752

)

-1.6

%

 
Net income (loss) per basic share

$

0.73

 

$

(0.08

)

Net income (loss) per diluted share

$

0.58

 

$

(0.08

)

 
Weighted average common shares outstanding – basic

 

167,491

 

 

166,315

 

Weighted average common shares outstanding – diluted

 

208,933

 

 

166,315

 

 
 
GAAP Basis
26 Weeks Ended
July 31, % of August 1, % of

2021

Revenue

2020

Revenue
Total net revenue

$

2,228,769

 

100.0

%

$

1,435,202

 

100.0

%

Cost of sales, including certain buying, occupancy and warehousing expenses

 

1,290,188

 

57.9

%

 

1,141,697

 

79.5

%

Gross profit

 

938,581

 

42.1

%

 

293,505

 

20.5

%

Selling, general and administrative expenses

 

558,430

 

25.1

%

 

411,908

 

28.7

%

Impairment, restructuring and COVID-19 related charges

 

 

0.0

%

 

170,231

 

11.9

%

Depreciation and amortization expense

 

78,727

 

3.5

%

 

81,844

 

5.7

%

Operating income (loss)

 

301,424

 

13.5

%

 

(370,478

)

-25.8

%

Interest expense (income), net

 

17,426

 

0.7

%

 

8,693

 

0.6

%

Other (income) expense, net

 

(3,223

)

-0.1

%

 

1,429

 

0.1

%

Income (loss) before income taxes

 

287,221

 

12.9

%

 

(380,600

)

-26.5

%

Provision (benefit) from income taxes

 

70,244

 

3.2

%

 

(109,685

)

-7.6

%

Net income (loss)

$

216,977

 

9.7

%

$

(270,915

)

-18.9

%

 
Net income (loss) per basic share

$

1.29

 

$

(1.63

)

Net income (loss) per diluted share

$

1.04

 

$

(1.63

)

 
Weighted average common shares outstanding – basic

 

168,036

 

 

166,461

 

Weighted average common shares outstanding – diluted

 

208,400

 

 

166,461

 

 
AMERICAN EAGLE OUTFITTERS, INC.
GAAP TO NON-GAAP RECONCILIATION
(Dollars in thousands, except per share amounts)
(unaudited)
 
13 Weeks Ended
July 31, 2021
Interest Expense, net Net Income Diluted Earnings per
Common Share
GAAP Basis

$

8,921

 

$

121,511

 

$

0.58

% of Revenue

 

0.8

%

 

10.2

%

 
Less: Convertible debt (1):

 

4,956

 

 

3,754

 

 

0.02

Non-GAAP Basis

$

3,965

 

$

125,265

 

$

0.60

% of Revenue

 

0.3

%

 

10.5

%

 
(1) Amortization of the non-cash discount on the Company’s convertible notes
 
   

AMERICAN EAGLE OUTFITTERS, INC.

GAAP TO NON-GAAP RECONCILIATION

(Dollars in thousands, except per share amounts)

(unaudited)

     

13 Weeks Ended

August 1, 2020 

Operating (Loss)

Income

Interest

Expense, net

Net (Loss)

Income

 

Diluted (Loss) per

Common Share

GAAP Basis

$

(12,237

)

$

8,547

 

$

(13,752

)

 

$

(0.08

)

% of Revenue

 

-1.4

%

 

1.0

%

-1.6

%

 
     
Add: Incremental COVID-19 related expenses and restructuring (1):

 

14,611

 

 

 

 

10,447

 

 

 

0.05

 

Less: Convertible debt (2):

 

 

 

3,949

 

 

2,826

 

 

 

0.03

 

Non-GAAP Basis

$

2,374

 

$

4,598

 

$

(479

)

 

$

(0.00

)

% of Revenue

 

0.3

%

 

0.5

%

 

-0.1

%

 
     

(1) $14.6 million incremental COVID-19 related expenses and restructuring charges:

-$13.9 million of incremental COVID-19 related expenses consisting of personal protective equipment and supplies for our associates and customers

– $0.7 million of corporate severance charges

(2) Amortization of the non-cash discount on the Company’s convertible notes
     
AMERICAN EAGLE OUTFITTERS, INC.
RESULTS BY SEGEMENT
(Dollars in thousands)
(unaudited)
 
 
American Eagle Aerie Corporate(1) Total(2)
13 weeks ended July 31, 2021
Total net revenue

$

845,882

 

$

335,795

$

12,479

 

$

1,194,156

 

Operating income (loss)

$

198,896

 

$

70,646

$

(101,546

)

$

167,996

 

Capital Expenditures

$

17,189

 

$

16,641

$

15,569

 

$

49,399

 

 
13 weeks ended August 1, 2020
Total net revenue

$

624,831

 

$

251,511

$

7,168

 

$

883,510

 

Operating income (loss)

$

59,603

 

$

30,404

$

(102,244

)

$

(12,237

)

Impairment, restructuring, and COVID-19 related charges

$

 

$

$

14,611

 

$

14,611

 

Adjusted operating income (loss)

$

59,603

 

$

30,404

$

(87,633

)

$

2,374

 

Capital Expenditures

$

6,774

 

$

8,620

$

12,098

 

$

27,492

 

 
American Eagle Aerie Corporate(1) Total(2)
26 weeks ended July 31, 2021
Total net revenue

$

1,573,584

 

$

633,282

$

21,903

 

$

2,228,769

 

Operating income (loss)

$

350,128

 

$

140,624

$

(189,328

)

$

301,424

 

Capital Expenditures

$

30,628

 

$

27,460

$

28,117

 

$

86,205

 

 
26 weeks ended August 1, 2020
Total net revenue

$

1,015,081

 

$

406,492

$

13,629

 

$

1,435,202

 

Operating income (loss)

$

(154,146

)

$

11,275

$

(227,607

)

$

(370,478

)

Impairment, restructuring, and COVID-19 related charges

$

90,926

 

$

18,215

$

61,090

 

$

170,231

 

Adjusted operating income (loss)

$

(63,220

)

$

29,490

$

(166,517

)

$

(200,247

)

Capital Expenditures

$

14,873

 

$

17,408

$

29,121

 

$

61,402

 

 
(1) Corporate includes revenue and operating results of the Todd Snyder and Unsubscribed brands, which are not material to disclose as separate reportable segments. Corporate operating costs represents certain costs that are not directly attributable to another reportable segment.
 
(2) The difference between Total Operating Income (loss) and Income (loss) before Taxes includes the following items, which are not allocated to our reportable segments:
 – For the 13 weeks ended July 31, 2021, interest expense, net or $8.9 million and other (income) expense, net of ($1.4) million. For the 26 weeks ended July 31, 2021, interest expense, net of $17.4 million and other (income) expense, net of ($3.2) million.
 – For the 13 weeks ended August 1, 2020, interest expense, net of $8.5 million and other (income) expense, net of ($1.6) million. For the 26 weeks ended August 1, 2020, interest expense, net of $8.7 million and other (income) expense, net of $1.4 million.
AMERICAN EAGLE OUTFITTERS, INC.
STORE INFORMATION
(unaudited)
 
Second Quarter YTD Second Quarter

2021

2021

Consolidated stores at beginning of period

1,074

 

1,078

 

Consolidated stores opened during the period
AE Brand

7

 

11

 

Aerie stand-alone(3)

12

 

18

 

Todd Snyder

1

 

1

 

Unsubscribed

0

 

1

 

Consolidated stores closed during the period
AE Brand

(4

)

(18

)

Aerie stand-alone(3)

0

 

(1

)

Total consolidated stores at end of period

1,090

 

1,090

 

AE Brand

894

 

Aerie stand-alone(3)

191

 

Aerie side-by-side(2)

183

 

Unsubscribed

2

 

Todd Snyder

3

 

 
Stores remodeled and refurbished during the period

8

 

11

 

Total gross square footage at end of period (in ‘000)

6,799

 

6,799

 

 
International license locations at end of period (1)

242

 

242

 

 
Aerie Openings
Aerie stand-alone(3)

12

 

18

 

Aerie side-by-side stores (2)

5

 

5

 

Total Aerie Openings

17

 

23

 

 
(1) International license locations are not included in the consolidated store data or the total gross square footage calculation.
(2) Aerie side-by-side and Offline side-by-side stores are included in the AE Brand store count as they are considered part of the AE Brand store to which they are attached.
(3) Aerie stand-alone stores include 1 OFFLINE opening YTD and 5 OFFLINE stores in the consolidated totals.

 

Olivia Messina

412-432-3300

[email protected]

KEYWORDS: Pennsylvania United States North America

INDUSTRY KEYWORDS: Fashion Online Retail Retail Consumer Women Men

MEDIA:

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Advantage Solutions to Participate at Upcoming Barclays Global Consumer Staples Conference

IRVINE, Calif., Sept. 02, 2021 (GLOBE NEWSWIRE) — Advantage Solutions Inc. (NASDAQ: ADV) (“Advantage,” the “Company,” “we” or “our”), the leading provider of outsourced sales and marketing services to consumer goods companies and retailers, today announced that its management team will attend the Barclays Global Consumer Staples Conference on September 10, 2021. Investors who are interested in setting up a meeting may contact Advantage Investor Relations or their Barclays conference representative.

About Advantage Solutions

Advantage Solutions is a leading business solutions provider committed to driving growth for consumer goods manufacturers and retailers through winning insights and execution. Advantage’s data and technology-enabled omnichannel solutions — including sales, retail merchandising, business intelligence, digital commerce and a full suite of marketing services — help brands and retailers across a broad range of channels drive consumer demand, increase sales and achieve operating efficiencies. Headquartered in Irvine, California, Advantage has offices throughout North America and strategic investments in select markets throughout Africa, Asia, Australia and Europe through which it services the global needs of multinational, regional and local manufacturers. For more information, please visit advantagesolutions.net. 

Contacts: 

Dan Riff
Chief Investor Relations & Strategy Officer
Advantage Solutions
[email protected]

Dan Morrison
Senior Vice President, Finance & Operations
Advantage Solutions

Kevin Doherty
Solebury Trout
Managing Director
[email protected]



AEye to Present at Upcoming Investor Conferences

AEye to Present at Upcoming Investor Conferences

DUBLIN, Calif.–(BUSINESS WIRE)–
AEye, Inc. (NASDAQ: LIDR) (“AEye”), the global leader in adaptive, high-performance LiDAR solutions, today announced that the Company will be presenting at the following virtual investor conferences.

Cowen 14th Annual Global Transportation & Sustainable Mobility Conference

Date: September 8, 2021

Presentation Time: 2:40 PM ET / 11:40 AM PT

Click here to view

Evercore ISI Autotech & AI Forum: New Paradigms In Mobility, Electrification, & Compute

Date: September 21, 2021

Presentation Time: 10:15am ET / 7:15am PT

Click here to view

BofA Future Car Conference 2021

Date: September 30, 2021

Presentation Time: 10:00 AM ET / 7:00 AM PT

A live webcast of the Cowen and Evercore conference presentations will be accessible in the Investor Relations section of AEye’s website at https://investors.aeye.ai/.

About AEye

AEye (NASDAQ: LIDR) is the premier provider of intelligent, next generation, adaptive LiDAR for vehicle autonomy, advanced driver-assistance systems (ADAS), and robotic vision applications. AEye’s iDAR™ (Intelligent Detection and Ranging) system leverages biomimicry and principles from automated targeting applications used by the military to scan the environment, intelligently focusing on what matters most, enabling faster, more accurate, and more reliable perception. iDAR is the only software configurable LiDAR with integrated deterministic artificial intelligence, delivering industry-leading performance in range, resolution, and speed. The company was founded in 2013 and is based in the San Francisco Bay Area.

Media Contact:

AEye, Inc.

Jennifer Deitsch

[email protected]

925-400-4366

Investors:

Financial Profiles, Inc.

Matt Keating

[email protected]

310-622-8230

John Brownell

[email protected]

310-622-8249

Source: AEye, Inc.

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Technology Alternative Vehicles/Fuels Automotive Automotive Manufacturing Manufacturing Audio/Video Software Hardware Data Management

MEDIA:

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Hostess Brands, Inc. to Participate in the Barclays Global Consumer Staples Conference

Hostess Brands, Inc. to Participate in the Barclays Global Consumer Staples Conference

LENEXA, Kan.–(BUSINESS WIRE)–
Hostess Brands, Inc. (Nasdaq: TWNK, TWNKW) (“Hostess” or the “Company”), a leading manufacturer and marketer of snacks including Twinkies®, Donettes®, CupCakes, Ding Dongs®, Voortman® wafers and cookies and a variety of other new and classic treats, announced today that Andy Callahan, President and Chief Executive Officer, and Brian Purcell, Chief Financial Officer, will participate in the Barclays Global Consumer Staples Conference. The Company will be hosting a fireside chat which will begin at 3:20 p.m. Eastern on September 9, 2021. fireside chat will be webcast live and will be available for replay, and can be found on the “News & Events” section of the Company’s website at www.hostessbrands.com.

About Hostess Brands, Inc.

Hostess Brands, Inc. is a leading packaged food company focused on developing, manufacturing, marketing, selling and distributing snack products in North America. The Hostess® brand’s history dates back to 1919, when the Hostess® CupCake was introduced to the public, followed by Twinkies® in 1930. Today, the Company produces a variety of new and classic treats in addition to Twinkies® and CupCakes, including Donettes®, Ding Dongs®, Zingers®, Danishes, Honey Buns and Coffee Cakes. In January 2020, the Company acquired Voortman Cookies Limited which produces a variety of cookies and wafers products, including sugar-free products under the Voortman® brand. For more information about Hostess® products and Hostess Brands, please visit hostesscakes.com. Follow Hostess on Twitter: @Hostess_Snacks; on Facebook: facebook.com/Hostess; on Instagram: Hostess_Snacks; and on Pinterest: pinterest.com/hostesscakes.

Investors, please contact:

Amit Sharma

[email protected]

Media, please contact:

Hannah Arnold and Marie Espinel

The LAKPR Group

[email protected] and [email protected]

KEYWORDS: United States North America Kansas

INDUSTRY KEYWORDS: Food/Beverage Retail

MEDIA:

Chevron, Bunge Announce Proposed Joint Venture to Create Renewable Fuel Feedstocks

Chevron, Bunge Announce Proposed Joint Venture to Create Renewable Fuel Feedstocks

SAN RAMON, Calif. & ST. LOUIS–(BUSINESS WIRE)–
Chevron U.S.A. Inc., a subsidiary of Chevron Corporation (NYSE: CVX), and Bunge North America, Inc., a subsidiary of Bunge Limited (NYSE: BG), announced today a memorandum of understanding (MOU) of a proposed 50/50 joint venture to help meet the demand for renewable fuels and to develop lower carbon intensity feedstocks.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210902005208/en/

Upon finalization of the joint venture, Chevron and Bunge’s partnership would establish a reliable supply chain from farmer to fueling station for both companies. Bunge is expected to contribute its soybean processing facilities in Destrehan, Louisiana, and Cairo, Illinois, and Chevron is expected to contribute approximately $600 million in cash to the joint venture. Through the joint venture, the two companies anticipate approximately doubling the combined capacity of the facilities from 7,000 tons per day by the end of 2024. The joint venture would also pursue new growth opportunities in lower carbon intensity feedstocks, as well as consider feedstock pretreatment investments.

“As the world’s largest oilseed processor, we are pleased to expand our partnership with an energy industry leader to increase our participation in the development of next generation, renewable fuels. Together, we share a commitment to sustainability and reducing carbon in the energy value chain. This relationship with Chevron would enable Bunge to better serve our farmer customers by accessing demand in the growing renewable fuels sector,” said Greg Heckman, Bunge CEO.

Under the proposed joint venture arrangement, Bunge will continue to operate the facilities, leveraging its expertise in oilseed processing and farmer relationships to manage origination and marketing of meal and plant-based oil. Chevron would have offtake rights to the oil to use as renewable feedstock to manufacture diesel and jet fuel with lower lifecycle carbon intensity, in addition to providing market knowledge and downstream retail and commercial distribution channels.

“Through our commercial work with Bunge, we have come to appreciate their strong company culture, their strategic desire to advance the production of lower carbon fuels, their commitment to capital discipline and promotion of sustainable agriculture in their supply chains,” said Mark Nelson, executive vice president of Downstream & Chemicals for Chevron. “Chevron’s proposed joint venture with Bunge positions us to expand into the renewable fuel feedstock value chain, which will advance our higher returns, lower carbon strategy.”

The creation of the proposed joint venture is subject to the negotiation of definitive agreements with customary closing conditions, including regulatory approval.

About Chevron

Chevron is one of the world’s leading integrated energy companies. We believe affordable, reliable and ever-cleaner energy is essential to achieving a more prosperous and sustainable world. Chevron produces crude oil and natural gas; manufactures transportation fuels, lubricants, petrochemicals and additives; and develops technologies that enhance our business and the industry. To advance a lower-carbon future, we are focused on cost efficiently lowering our carbon intensity, increasing renewables and offsets in support of our business, and investing in low-carbon technologies that enable commercial solutions. More information about Chevron is available at www.chevron.com.

About Bunge Limited

Bunge (www.bunge.com, NYSE: BG) is a world leader in sourcing, processing and supplying oilseed and grain products and ingredients. Founded in 1818, Bunge’s expansive network feeds and fuels a growing world, creating sustainable products and opportunities for more than 70,000 farmers and the consumers they serve across the globe. The company is headquartered in St. Louis, Missouri and has almost 23,000 employees worldwide who stand behind approximately 300 port terminals, oilseed processing plants, grain facilities, and food and ingredient production and packaging facilities around the world.

CAUTIONARY STATEMENTS RELEVANT TO FORWARD-LOOKING INFORMATION FOR THE PURPOSE OF “SAFE HARBOR” PROVISIONS OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

This news release contains forward-looking statements relating to Chevron’s operations that are based on management’s current expectations, estimates and projections about the petroleum, chemicals and other energy-related industries. Words or phrases such as “anticipates,” “expects,” “intends,” “plans,” “targets,” “advances,” “commits,” “forecasts,” “projects,” “believes,” “approaches,” “seeks,” “schedules,” “estimates,” “positions,” “pursues,” “may,” “could,” “should,” “will,” “budgets,” “outlook,” “trends,” “guidance,” “focus,” “on track,” “goals,” “objectives,” “strategies,” “opportunities,” “poised,” “potential” and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors, many of which are beyond the company’s control and are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The reader should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. Unless legally required, Chevron undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Among the important factors that could cause actual results to differ materially from those in the forward-looking statements are: changing crude oil and natural gas prices and demand for our products, and production curtailments due to market conditions; crude oil production quotas or other actions that might be imposed by the Organization of Petroleum Exporting Countries and other producing countries; public health crises, such as pandemics (including coronavirus (COVID-19)) and epidemics, and any related government policies and actions; changing economic, regulatory and political environments in the various countries in which the company operates; general domestic and international economic and political conditions; changing refining, marketing and chemicals margins; the company’s ability to realize anticipated cost savings, expenditure reductions and efficiencies associated with enterprise transformation initiatives; actions of competitors or regulators; timing of exploration expenses; timing of crude oil liftings; the competitiveness of alternate-energy sources or product substitutes; technological developments; the results of operations and financial condition of the company’s suppliers, vendors, partners and equity affiliates, particularly during extended periods of low prices for crude oil and natural gas during the COVID-19 pandemic; the inability or failure of the company’s joint-venture partners to fund their share of operations and development activities; the potential failure to achieve expected net production from existing and future crude oil and natural gas development projects; potential delays in the development, construction or start-up of planned projects; the potential disruption or interruption of the company’s operations due to war, accidents, political events, civil unrest, severe weather, cyber threats, terrorist acts, or other natural or human causes beyond the company’s control; the potential liability for remedial actions or assessments under existing or future environmental regulations and litigation; significant operational, investment or product changes required by existing or future environmental statutes and regulations, including international agreements and national or regional legislation and regulatory measures to limit or reduce greenhouse gas emissions; the potential liability resulting from pending or future litigation; the company’s ability to achieve the anticipated benefits from the acquisition of Noble Energy, Inc.; the company’s future acquisitions or dispositions of assets or shares or the delay or failure of such transactions to close based on required closing conditions; the potential for gains and losses from asset dispositions or impairments; government mandated sales, divestitures, recapitalizations, industry-specific taxes, tariffs, sanctions, changes in fiscal terms or restrictions on scope of company operations; foreign currency movements compared with the U.S. dollar; material reductions in corporate liquidity and access to debt markets; the receipt of required Board authorizations to pay future dividends; the effects of changed accounting rules under generally accepted accounting principles promulgated by rule-setting bodies; the company’s ability to identify and mitigate the risks and hazards inherent in operating in the global energy industry; and the factors set forth under the heading “Risk Factors” on pages 18 through 23 of the company’s 2020 Annual Report on Form 10-K and in other subsequent filings with the U.S. Securities and Exchange Commission. Other unpredictable or unknown factors not discussed in this news release could also have material adverse effects on forward-looking statements

Cautionary Statement Concerning Forward-Looking Statements

This Bunge press release contains both historical and forward-looking statements. All statements, other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are not based on historical facts, but rather reflect our current expectations and projections about our future results, performance, prospects and opportunities. We have tried to identify these forward-looking statements by using words including “may,” “will,” “should,” “could,” “expect,” “anticipate,” “believe,” “plan,” “intend,” “estimate,” “continue” and similar expressions. These forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, prospects or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. The following important factors, among others, could cause actual results to differ from these forward-looking statements: the negotiation and finalization of the definitive documentation related to the joint venture; the ability to achieve the expected targets of the joint venture and the ability to realize the benefits we expect to derive from it; the outcome and effects of the Board’s strategic review; our ability to attract and retain executive management and key personnel; industry conditions, including fluctuations in supply, demand and prices for agricultural commodities and other raw materials and products used in our business; fluctuations in energy and freight costs and competitive developments in our industries; the effects of weather conditions and the outbreak of crop and animal disease on our business; global and regional agricultural, economic, financial and commodities market, political, social and health conditions; the outcome of pending regulatory and legal proceedings; our ability to complete, integrate and benefit from acquisitions, dispositions, joint ventures and strategic alliances; our ability to achieve the efficiencies, savings and other benefits anticipated from our cost reduction, margin improvement and other business optimization initiatives; changes in government policies, laws and regulations affecting our business, including agricultural and trade policies, tax regulations and biofuels legislation; and other factors affecting our business generally. The forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by federal securities law, we do not have any obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.

Investor Contacts:

Roderick Green

Chevron

[email protected]

Ruth Ann Wisener

Bunge Limited

636-292-3014

[email protected]

Media Contacts:

Tyler Kruzich

Chevron

925-549-8686

[email protected]

Bunge News Bureau

Bunge Limited

636-292-3022

[email protected]

KEYWORDS: United States North America Illinois California Missouri Louisiana

INDUSTRY KEYWORDS: Environment Oil/Gas Alternative Energy Agriculture Energy Natural Resources

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Box to Present at Investor Conferences

Box to Present at Investor Conferences

REDWOOD CITY, Calif.–(BUSINESS WIRE)–
Box, Inc. (NYSE:BOX), the leading Content Cloud, today announced that Aaron Levie, co-founder and CEO, and Dylan Smith, co-founder and CFO, will present at the following conferences:

Deutsche Bank 2021 Technology Conference

Date and Time: September 10, 2021 at 12:05pm ET

Location: Virtual event; webcast

Jefferies Virtual Software Conference

Date and Time: September 14 at 3:30pm ET

Location: Virtual event; webcast

These events will be webcast live at www.box.com/investors and will be available for replay beginning approximately one hour after the live event. The Deutsche Bank replay will be available for a period of ninety (90) days, and the Jefferies replay will be available for a period of thirty (30) days.

About Box

Box (NYSE:BOX) is the leading Content Cloud that enables organizations to accelerate business processes, power workplace collaboration, and protect their most valuable information, all while working with a best-of-breed enterprise IT stack. Founded in 2005, Box simplifies work for leading organizations globally, including AstraZeneca, JLL, and Morgan Stanley. Box is headquartered in Redwood City, CA, with offices across the United States, Europe, and Asia. To learn more about Box, visit http://www.box.com. To learn more about how Box powers nonprofits to fulfill their missions, visit Box.org.

Safe Harbor for Forward-Looking Statements

During the course of this event, Box will make forward-looking statements regarding future events or the future financial performance of the company. Statements including words such as “anticipate,” “believe,” “estimate,” or “expect” and statements in the future tense are forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual events or actual future results to differ materially from those set forth in the forward-looking statements. Please refer to Box’s latest Quarterly Report on Form 10-Q for the fiscal quarter ended April 30, 2021 for a discussion of important factors that could cause actual events or actual results to differ materially from those discussed during this event. These forward-looking statements speak only as of the date this event; Box assumes no obligation, and does not necessarily intend, to update these forward-looking statements.

Investors:

Cynthia Hiponia / Elaine Gaudioso

+1 650-209-3463

[email protected]

Media:

Rachel Levine

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Data Management Security Technology Mobile/Wireless Software Networks Internet

MEDIA:

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Rhythm Pharmaceuticals to Present at Morgan Stanley 19th Annual Global Healthcare Conference

BOSTON, Sept. 02, 2021 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that David Meeker, M.D., Chair, President and Chief Executive Officer, will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Thursday, September 9, 2021 at 8:45 a.m. ET.

A live webcast of the presentation will be available under “Events & Presentations” in the Investor Relations section of the Company’s website at www.rhythmtx.com. A replay of the webcast will be available on the Rhythm website for 30 days following the presentation.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the treatment paradigm for people living with rare genetic diseases of obesity. The Company’s precision medicine, IMCIVREE® (setmelanotide), was approved in November 2020 by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to POMC, PCSK1 or LEPR deficiency confirmed by genetic testing and by the European Commission (EC) in July 2021 for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE is the first-ever FDA and EC-approved therapy for patients with these rare genetic diseases of obesity. Rhythm is advancing a broad clinical development program for setmelanotide in other rare genetic diseases of obesity. The Company is leveraging the Rhythm Engine and the largest known obesity DNA database—now with approximately 37,500 sequencing samples—to improve the understanding, diagnosis and care of people living with severe obesity due to certain genetic deficiencies. The company is based in Boston, MA.

IMCIVREE

®

 (setmelanotide) Indication

In the United States, IMCIVREE is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. The condition must be confirmed by genetic testing demonstrating variants in POMCPCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the EU, IMCIVREE is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 6 years of age and above. IMCIVREE should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

IMCIVREE is not indicated for the treatment of patients with the following conditions as IMCIVREE would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMCPCSK1, or LEPR variants classified as benign or likely benign;
  • Other types of obesity not related to POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Important Safety Information

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Sexual adverse reactions may occur in patients treated with IMCIVREE. Spontaneous penile erections in males and sexual adverse reactions in females occurred in clinical studies with IMCIVREE. Instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Some drugs that target the central nervous system, such as IMCIVREE, may cause depression or suicidal ideation. Monitor patients for new onset or worsening of depression. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors.

Skin Pigmentation and Darkening of Pre-Existing Nevi: IMCIVREE may cause generalized increased skin pigmentation and darkening of pre-existing nevi due to its pharmacologic effect. This effect is reversible upon discontinuation of the drug. Perform a full body skin examination prior to initiation and periodically during treatment with IMCIVREE to monitor pre-existing and new skin pigmentary lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants.

ADVERSE REACTIONS

  • The most common adverse reactions (incidence ≥23%) were injection site reactions, skin hyperpigmentation, nausea, headache, diarrhea, abdominal pain, back pain, fatigue, vomiting, depression, upper respiratory tract infection, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

Treatment with IMCIVREE is not recommended for use while breastfeeding.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See Full Prescribing Information for IMCIVREE.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical progress of setmelanotide and our participation in upcoming events and presentations. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, our liquidity and expenses, the impact of the COVID-19 pandemic on our business and operations, including our preclinical studies, clinical trials and commercialization prospects, and general economic conditions, and the other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact:

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected] 

Investor Contact:

Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
[email protected] 

Media Contact:

Adam Daley
Berry & Company Public Relations
212-253-8881
[email protected]